Senior QA Specialist, Equipment & Cleaning Validation

INCOG BioPharma Services•Fishers, IN

1d•Onsite

About The Position

Are you passionate about ensuring that pharmaceutical manufacturing equipment and systems are qualified, maintained, and compliant throughout their life cycle? At INCOG BioPharma, our Quality Assurance team is growing, and we are looking for a hands-on validation professional who thrives in a fast-paced, collaborative CDMO environment. You will work alongside Engineering, Manufacturing, and Technical Services teams, serving as the QA subject matter expert for validation. This is an opportunity to make a direct impact on patient safety by ensuring our equipment and systems meet the highest regulatory standards. The Senior Quality Validation Specialist provides Quality Assurance oversight of validation activities across the site, with a focus on new equipment commissioning and qualification, equipment change controls, and equipment life cycle documentation. This role is responsible for ensuring that User Requirements Specifications (URS), risk assessments, qualification protocols, and cleaning validation activities are compliant with applicable regulatory expectations, industry guidance documents, and internal procedures. The Senior Quality Validation Specialist will have review and approval responsibilities for qualification protocols, execution, reports, and system life cycle documentation.

Requirements

Bachelor’s degree in a science or engineering field (e.g., Chemistry, Biology, Biochemistry, Chemical Engineering, Mechanical Engineering, or related discipline).
Minimum of 5 years of experience in pharmaceutical, biopharmaceutical, or CDMO manufacturing with direct involvement in equipment qualification and validation activities.
Demonstrated hands-on experience in designing and executing FAT/SAT, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
Direct experience with cleaning validation programs, including protocol development, sampling strategies, analytical method considerations, and acceptance criteria establishment.
Working knowledge of equipment and system life cycle management, including URS development, risk assessments, qualification, and periodic review.
Thorough understanding of FDA, EMA, and ICH regulatory requirements and guidance documents applicable to equipment qualification and cleaning validation (e.g., FDA Process Validation Guidance, EU Annex 15, ISPE Commissioning and Qualification Baseline Guide).
Familiarity with commissioning and qualification of utility systems (e.g., WFI, clean steam, compressed gases) and aseptic processing equipment (e.g., filling lines, lyophilizers, autoclaves, isolators).
Experience with risk-based qualification approaches and ASTM E2500 methodology.
Working knowledge of computerized system validation (CSV) and data integrity principles as they relate to equipment and systems.

Nice To Haves

Experience in a sterile injectable or aseptic manufacturing environment, particularly within a CDMO setting.
Prior experience supporting regulatory inspections (FDA, EMA, Health Canada) or client audits related to validation activities.

Responsibilities

Provide QA oversight and approval of equipment commissioning and qualification activities, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Review and approve equipment life cycle documents including User Requirements Specifications (URS), risk assessments (e.g., FMEA), acceptance (FAT/SAT) and qualification protocols, summary reports, and periodic reviews.
Oversee equipment change controls from initiation through closure, ensuring appropriate qualification impact assessments are performed and documented.
Provide QA oversight of cleaning validation activities, including review and approval of cleaning validation protocols, sampling plans, acceptance criteria, and summary reports.
Hands-on design and execution of qualification protocols and associated testing for new and modified equipment and systems.
Ensure all validation activities are performed in compliance with FDA, EMA, and applicable regulatory requirements, ICH guidelines, and internal SOPs.
Participate in the development, review, and revision of validation-related SOPs, policies, and guidance documents.
Serve as a QA subject matter expert during internal and external audits and regulatory inspections related to validation and qualification activities.
Support deviation investigations and CAPA activities related to equipment qualification, cleaning validation, and system life cycle management.
Collaborate cross-functionally with Engineering, Manufacturing, Technical Services, and other Quality groups to ensure validation activities are aligned with project timelines and regulatory expectations.
Maintain current knowledge of regulatory trends, guidance documents, and industry best practices related to equipment qualification, cleaning validation, and system life cycle management.